United States District Court, D. Maryland
IN RE SMITH & NEPHEW BIRMINGHAM HIP RESURFACING (BHR) HIP IMPLANT PRODUCTS LIABILITY LITIGATION
DOCUMENT RELATES TO ALL THA TRACK CASES
CATHERINE C. BLAKE JUDGE
before the court is Smith & Nephew's motion to
dismiss claims in the THA track. The motion boils down to one
core dispute: how does the express preemption provision of
the Medical Device Amendments of 1976 (the "MDA")
apply to hybrid systems that are comprised of both
premarket-approved and § 510(k)-approved components? The
Fourth Circuit has yet to address this question, and
resolving the issue calls for careful consideration of the
interrelated, and sometimes competing, concerns that underlie
the U.S. Food and Drug Administration's (the
"FDA") premarket. approval process and the
MDA's preemption provision-namely, ensuring public safety
while encouraging innovation. For the reasons outlined below,
Smith & Nephew's motion will be granted in part and
denied in part.
& Nephew seeks to dismiss claims in two of the
plaintiffs' Master Amended Consolidated Complaints
("MACCs"). First, the plaintiffs filed a MACC that
alleges harm from the use of Smith & Nephew's
Birmingham Hip Resurfacing ("BHR") cup with Smith
& Nephew's cobalt-chrome modular femoral heads as
part of total hip arthroplasties ("THA"). (MACC
["THA MACC], ECF No. 878). Second, the plaintiffs filed
a MACC that alleges harm from the use of Smith &
Nephew's R3 metal liner during THAs with a metal modular
femoral head and/or with the R3 acetabular shell. (MACC
["R3 MACC"], ECF No. 966). Following the
parties' lead, and for the sake of efficiency, the court
will refer to these two hybrid systems as the BHR-THA and the
plaintiffs allege that Smith & Nephew was aware of the
dangers posed by metal-on-metal devices, which create
"metal wear debris" over time. (THA MACC
¶¶ 23-31, 40-54; R3 MACC ¶¶ 47-53). The
metal ions produced from this wear-and-tear are toxic, can
destroy human tissue, and often lead to the failure of the
hip implant, requiring revision surgery. (THA MACC
¶¶ 23-24, 32-34). Despite this risk, the plaintiffs
allege Smith & Nephew promoted the use of the BHR cup
with metal modular femoral heads and stems and the use of the
R3 metal liner with the R3 acetabular shell well after
competitor products were withdrawn from the market. (THA MACC
¶¶ 36; R3 MACC ¶¶ 63-65). The plaintiffs
further allege that Smith & Nephew made public statements
implying that the BHR-THA and R3-THA systems were safe, (THA
MACC ¶¶ 59, 79, 81, 83; R3 MACC ¶¶
15-16), publicly indicated that the R3 metal liner could be
used with the R3 acetabular system, (R3 MACC ¶ 15),
promoted both the BHR-THA and the R3-THA systems through its
sales representatives, (see e.g., THA MACC ¶
121; R3 MACC ¶¶ 17-20, 38), circulated information
to physicians that implied the BHR-THA and R3-THA systems
were safe, and withheld critical safety and efficacy
information from physicians, (see e.g., THA MACC
¶¶ 61, 63-64, 68-69, 284-85; R3 MAC ¶¶
23, 37-38, 40, 81, 88-89).
plaintiffs allege that Smith & Nephew promoted the
BHR-THA and R3-THA systems even though the FDA refused to
certify the safety of either system through the premarket
approval process. (THA MACC ¶¶ 63, 70; R3 MACC
¶¶ 9, 14). In fact, the FDA explicitly indicated
that the metal modular femoral heads were intended for use
with a "natural acetabular" to avoid the release of
metal debris that can occur from metal-on-metal devices, (THA
MACC ¶ 97), and the FDA stated that the "R3 metal
liner should not be used with the R3 acetabular shell,"
(R3 MACC ¶¶ 9, 11). Patients who received the
BHR-THA and R3-THA systems suffered adverse reactions and
underwent revision surgeries. (See, e.g., .THA MACC
¶ 32; R3 MACC ¶¶ 60, 65).
motion to dismiss, Smith & Nephew sets forth several
arguments: (1) the plaintiffs' strict liability, implied
warranty, misrepresentation, deceptive trade practices, and
fraudulent concealment arguments are preempted by the MDA;
(2) several of the plaintiffs' claims are not pled with
the particularity required by Rule 8 and Rule 9(b); and (3)
the court should reconsider its ruling in the BHR track that
several of the plaintiffs' claims at least superficially
ruling on a motion under Rule 12(b)(6), the court must
"accept the well-pled allegations of the complaint as
true," and "construe the facts and reasonable
inferences derived therefrom in the light most favorable to
the plaintiff." Ibarra v. United States, 120
F.3d 472, 474 (4th Cir. 1997). "Even though the
requirements for pleading a proper complaint are
substantially aimed at assuring that the defendant be given
adequate notice of the nature of a claim being made against
him, they also provide criteria for defining issues for trial
and for early disposition of inappropriate complaints."
Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir.
2009). "The mere recital of elements of a cause of
action, supported only by conclusory statements,, is not
sufficient to survive a motion made pursuant to Rule
12(b)(6)." Walters v. McMahen, 684 F.3d 435,
439 (4th Cir. 2012) (citing Ashcroft v. Iqbal, 556
U.S. 662, 678 (2009)). To survive a motion to dismiss, the
factual allegations of a complaint "must be enough to
raise a right to relief above the speculative level on the
assumption that all the allegations in the complaint are true
(even if doubtful in fact)." Bell Atlantic Corp. v.
Twombly, 550 U.S. 544, 555 (2007) (internal citations
omitted). "To satisfy this standard, a plaintiff need
not 'forecast' evidence sufficient to prove the
elements of the claim. However, the complaint must allege
sufficient facts to establish those elements."
Walters, 684 F.3d at 439 (citation omitted).
"Thus, while a plaintiff does not need to demonstrate in
a complaint that the right to relief is 'probable,'
the complaint must advance the plaintiffs claim 'across
the line from conceivable to plausible.'"
Id. (quoting Twombly, 550 U.S. at 570).
Medical Device Amendments of 1976
1976, in response to "mounting consumer and regulatory
concern" about the health risks posed by new medical
devices, the FDA passed the MDA. Medtronic, Inc. v.
Lohr, 518 U.S. 470, 475-76 (1996); Riegel v.
Medtronic, Inc., 522 U.S. 312, 315-16 (2018). Expanding
the scope of the Federal Food, Drug, and Cosmetic Act (the
"FDCA"), the MDA established federal requirements
for the introduction of new devices and included an express
preemption provision that preempts conflicting state law.
See Medical Device Amendments of 1976, Pub. L. No.
94-295, sec. 2, §§ 513-516, 521, 90 Stat. 539,
540-60, 562 (codified as amended at 21 U.S.C. §§
360c-360f, 360k). The MDA established three classes of
medical devices, tiering devices based upon the potential
risk posed to human health: Class I, Class II, and Class III.
21 U.S.C. § 360c. Class I medical devices are the most
benign, while Class III medical devices pose the most
potential risk to human life and welfare and, therefore, are
subject to the most stringent regulations. Id.; see
Riegel, 522 U.S. at 317.
a manufacturer can release a Class III device to the public,
it must proceed through the premarket approval
("PMA") process. See 21 U.S.C. §
360c(a)(1)(C). A device will receive premarket approval only
if the FDA determines, after considering "any probable
benefit to health from the use of the device against any
probable risk of injury or illness from such use," that
"there is a 'reasonable assurance' of the
device's 'safety and effectiveness.'"
Riegel, 552 U.S. at 318 (quoting 21 U.S.C.
§§ 360c(a)(2)(C), 360e(d)). The premarket approval
process is demanding. On average, before rendering a decision
on any Class III device, the FDA spends 1, 200 hours
reviewing the manufacturer's submissions and data related
to the device's safety and efficacy. Lohr, 518
U.S. at 477 (first citing Hearings before the Subcommittee on
Health and the Environment of the House Committee on Energy
& Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p.
384 (1987) (hereinafter 1987 Hearings), and then citing
Kahan, Premarket Approval Versus Premarket Notification:
Different Routes to the Same Market, 39 FOOD DRUG Cosm.
L.J. 510, 512-14(1984)).
must provide the FDA with a range of information, including
"a full statement of the [device's] components,
ingredients, and properties," 21 U.S.C. §
360e(c)(1)(B); Riegel, 552 U.S. at 317-18, and a
"specimen of the proposed labeling" that details
"conditions of use," Riegel, 552 U.S. at
318; 21 U.S.C. § 360e(c)(1)(F). The FDA also reviews the
manufacturer's proposed labeling to ensure that it is not
false or misleading. Riegel, 552 U.S. at 318; 21
U.S.C. § 360e(d)(1)(A). "Once approved, the device
may be manufactured, advertised, and distributed to the
public, but those marketing activities may not be done in a
manner 'inconsistent with ... the [premarket] approval
order for the device.'" Shaker v. Smith &
Nephew, PLC, 885 F.3d 760, 766 (2018) (quoting 21 C.F.R.
manufacturers are required to inform the FDA of "new
clinical investigations or scientific studies concerning the
device which the [manufacturer] knows of or reasonably should
know of," and to "report incidents in which the
device may have caused or contributed to death or serious
injury." Riegel, 552 U.S. at 319 (first citing
21 C.F.R. § 814.84(b)(2), and then citing §
803.50(a)). Manufacturers of premarket-approved products are
also required to investigate adverse reports to determine if
remedial action is required to prevent substantial harm to
the public health, 21 C.F.R. § 803.50, and to report
these findings to the FDA within five days, 21 C.F.R. §
803.53. If manufacturers want to make changes to a PMA
approved device, they must submit an application for
"supplemental premarket approval" to the FDA.
§ 360e(d)(5); 21 C.F.R. § 814.39(c). Finally, the
FDA may withdraw premarket approval if it "determines
that a device is unsafe or ineffective."
Riegel, 552 U.S. at 319-20 (first citing §
360e(e)(1), and then citing § 360h(e)).
however, not all Class III devices are approved through the
PMA process. The MD A provides for two exceptions to the PMA
requirement. First, the MDA allowed devices which were
already on the market as of 1976 to "remain on the
market without FDA approval until such time as the FDA
initiates and completes the requisite PMA."
Lohr, 518 U.S. at 478 (first citing 21 U.S.C. §
360e(b)(1)(A), and then citing 21 C.F.R. § 814.1(c)(1)
(1995)). "Second, to prevent manufacturers of
grandfathered devices from monopolizing the market while new
devices clear the PMA hurdle, and to ensure that improvements
to existing devices can be rapidly introduced into the
market, the Act  permits devices that are
'substantially equivalent' to pre-existing devices to
avoid the PMA process." Lohr, 518 U.S. at 478
(citing 21 U.S.C. § 360e(b)(1)(B)). This approval
process for substantially equivalent devices, described in
further detail below, is known as the § 510(k) process.
See 21 U.S.C. § 360(k).
510 (k) Approval Process
many Class I, II, and III devices are reviewed through the
comparatively lenient §510(k) process. See 21
U.S.C. § 360(k). On average, the FDA spends a mere 20
hours determining whether to approve a device through the
§ 510(k) process. Lohr, 518 U.S. at 479 (citing
1987 Hearings, at 384). And clearing the § 510(k)
process does not require an independent or exhaustive review
of a device's safety and efficacy. Lohr, 518
U.S. at 479; Shuker, 885 F.3d at 767. Instead,
manufacturers submit a "premarket notification" to
the FDA, and the device may be cleared for the market if it
is "substantially equivalent" to an existing
designing the MDA, Congress expected that most Class III
devices would be approved for market through the PMA process.
Lohr, 518 U.S. at 479. But because of the
comparative ease of receiving approval through the §
510(k) process, many Class III devices enter the market
without proceeding through the PMA process. In fact, by 1983,
"nearly 1, 000 of approximately 1, 100 Class III devices
that had been introduced to the market since 1976" were
processed through the § 510(k) process instead of the
PMA process. Id. (citing Medical Device Regulation:
The FDA's Neglected Child (Committee Print compiled for
the Subcommittee on Oversight and Investigations of the House
Committee on Energy & Commerce), Comm. Print 98-F, p. 34
(1983)). By 1990, "80% of new Class III devices were
being introduced to the market through the § 510(k)
process and without PMA review." Lohr, 518 U.S.
at 479 (citing H.R.Rep. No. 101-808, p. 14 (1990)).
Congress amended the MDA in an attempt to decrease "the
FDA's reliance on the § 510(k) process while
continuing to ensure that particularly risky devices received
full PMA review." Lohr, 518 U.S. at 479 n.4
(citing Safe Medical Devices Act of 1990, 104 Stat. 4511).
Despite these amendments, the § 510(k) approval process
continues to be overwhelmingly preferred. In 2005, for
example, the FDA approved 3, 148 Class III devices through
the § 510(k) process compared to a meager 32 devices
through the PMA process. Riegel, 552 U.S. at 317
(citing P. Hutt, R. Merril, & L. Grossman, Food &
Drug Law 992 (3d ed. 2007)).
MDA's Express Preemption Provision
differences in rigor between the PMA and § 510(k)
approval processes, the processes also impart distinct
preemption consequences. The MDA contains an express
preemption provision, which reads: "no State .. . may
establish or continue in effect with respect to a device...
any requirement which is different from, or in addition
to," any federal requirement that relates either
"to the safety or effectiveness of the device" or
"to any other matter" included in a federal
requirement applicable to the device. 21 U.S.C. §
360k(a). The Supreme Court has held that premarket approval
establishes federal "requirement[s]" under the MDA.
Riegel, 552 U.S. at 322-23. By contrast, the §
510(k) process does not establish federal requirements
because it "focuse[s] on equivalence, not
safety." Id. at 323 (citing Lohr, 518
U.S. at 493). Accordingly, state law may not impose
requirements on PMA approved devices that depart from, or
expand upon, federal requirements. But parallel state-law
claims that mirror the federal requirements established by
the MDA are not preempted. Lohr, 518 U.S. at 494-95.
Importantly, state claims need not be identical to federal
requirements to survive explicit preemption, they need only
be "narrower, not broader" than existing federal
requirements. See Lohr, 518 U.S. at 495 ("While
such a narrower requirement might be 'different from'
the federal rules in a literal sense, such a difference would
surely provide a strange reason for finding preemption of a
state rule insofar as it duplicates the federal rule.");
see also id, (Breyer, J., joining the Court's
opinion as to Part V).
determining whether state-law claims are preempted under
§ 360k(a) requires a two-step analysis: (1) has the
federal government established requirements applicable to the
specific device?; and (2) if so, do the plaintiffs'
state-law claims impose state requirements "with respect
to the device that are 'different from, or in addition
to,' the federal ones, and that relate to safety and
efficacy"? See Riegel, 552 U.S. at 321-22
(quoting 21 U.S.C. § 360k(a)). Claims will be preempted
only if both of these questions are answered in the